Pocket Warming of Epidural Medication

Pocket Warming of Epidural Medication to Shorten Onset of Labor Analgesia

This study will examine recent claims regarding the beneficial effect of warming epidural medications in order to hasten the onset of labor analgesia.

Study Overview

• Status: Recruiting
• Conditions: Epidural Anesthesia in Labor and Delivery
• Intervention / Treatment: Other: Pocket-warming; Other: Standard of Care Labor Epidural

Detailed Description

Studies have shown that warmed epidural medication resulted in a mean analgesic onset of 9.2 minutes as compared to a mean onset of 16 minutes for the same medication at room temperature. Onset time for pain medication during labor is important to a great many participants, thus techniques to shorten analgesic onset are relevant to daily clinical practice. Combined-spinal epidural (CSE) techniques have been used to improve the onset and reliability of labor analgesia compared to epidural techniques; however, CSEs have risks associated with their usage. Firstly, is not always possible to administer a spinal dose despite successful loss-of resistance with CSE techniques, providing less satisfactory labor analgesia, and secondly, the CSE technique has been associated with a greater incidence of non-reassuring fetal heart tones (FHT), uterine hyperactivity, maternal pruritis, and greater incidence of neurologic sequelae compared to epidural analgesia. Further, CSE labor analgesia is more likely to result in prolonged FHT decelerations if there is FHT abnormalities prior to the neuraxial procedure. Given these potential limitations of CSE techniques for labor analgesia, epidural medication warming may represent an effective alternative for safe and satisfactory labor analgesia.

Previous studies in obstetric and non-obstetric patients undergoing surgery have demonstrated a more rapid onset of sensory blockade in patients receiving body temperature (37 °C) epidural medication compared to room temperature medication, though other reports have found no significant difference in the onset of sensory blockade when comparing body temperature to room temperature epidural medications. To the knowledge of the investigators, there are few studies examining the effect of warmed epidural medications for patients receiving epidural labor analgesia.

In the experience of the investigators' colleagues, the close proximity to the body has a warming effect on the epidural medication and ultimately leads to quicker onset of pain relief once administered. Pocket warming does not warm the medications to the same extent as an incubator, but is certainly less expensive and is readily available to every obstetric anesthesia practice.

The investigators have previously measured the temperature of five 10mL syringes of normal saline at room temperature and at baseline the average was 21.7 °C (range 21.5-21.9 °C), and increased to an average of 29.7 °C (range 29.1 - 30.2 °C) after 1.5 hours of pocket warming. It has not been studied and is unknown if this degree of warming would be effective in enhancing the onset of labor analgesia, but such information is valuable given that an approximate 30 °C temperature may be accomplished by simple pocket warming and is within manufacturer recommended storage temperatures of 15-30 °C.

The investigators also assessed the potential for epidural medication cooling by measuring the temperature of one of the investigator's 10mL saline syringes for twenty minutes after removal from the warm pocket environment. The initial temperature of 30.0 °C had cooled to 27.0 °C by five minutes, 24.7 °C by ten minutes, 22.9 °C by fifteen minutes, and had returned to baseline room temperature by twenty minutes. The time between medication removal and dosing is important to consider given that significant cooling may occur and negate any potential benefits of warming the medication. This cooling effect makes use of a centralized warmer less promising, as it could take 10-20 minutes to position the patient and complete placement of the epidural catheter prior to dosing the medication. The use of a bedside incubator or a pocket warming technique would be useful in this regard, because the medication could be administered immediately after removal from the warm environment.

The investigators hypothesize that pocket warming in the front, upper pocket would be beneficial in enhancing onset of labor analgesia relative to room temperature medication.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juan Fiorda, MD; Phone Number: 614-293-3559; Email: juan.fiorda@osumc.edu
• Study Contact Backup: Name: John Coffman, MD; Phone Number: 614-293-8487; Email: john.coffman@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Wexner Medical Center
      • Contact: Juan Fiorda, MD; Phone Number: 614-293-3559; Email: juan.fiorda@osumc.edu
      • Contact: John Coffman, MD; Phone Number: 614-293-8487; Email: john.coffman@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Women with a single vertex presentation fetus at term (38-42 weeks)
2. Intact fetal membranes or membrane rupture <6 hours previously
3. Request to have an epidural for labor analgesia
4. Provide written consent for the study.

Exclusion Criteria:

1. Patients being treated/managed for chronic pain
2. Allergies or significant adverse reactions to local anesthetic or opioid medications
3. Contraindication to labor epidural placement
4. Patients with history of spine abnormalities or spine surgery
5. Clinical signs or symptoms of infection
6. Baseline temperature > 37.6 °C
7. Non-English speaking
8. Prisoners
9. Age less than 18 years old

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pocket-warmed epidural medication; This arm will consist of pocket-warmed epidural medications to be administered per standard protocol to patients randomized to this group; this group is the pocket-warming group.	Other: Pocket-warming; Pocket-warming of epidural medication
Active Comparator: Room-temperature epidural medication; This arm will consist of room-temperature epidural medications to be administered per standard protocol to patients randomized to this group. This group has no experimental intervention; standard of care labor epidural.	Other: Standard of Care Labor Epidural; Labor epidural medication administered per standard of care; no pocket warming.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time until pain score less than or equal to 3	Assess pain level regularly during labor	duration of labor and delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Labor analgesia satisfaction	Patients will assess initiation of labor analgesia using a 1-100 point rating scale at their routine follow-up visit.	first hour of epidural administration
Vital Signs	oral temperature, fever (temperature greater than 38 °C), nausea, vomiting, shivering, and blood pressure will be measured during the first 60 minutes of labor analgesia. Fever at any time during labor will be recorded.	during labor and delivery
Breakthrough pain	number of required rescue epidural boluses, time until first manual epidural rescue bolus, and total number of manual anesthetic interventions to treat inadequate labor analgesia will be recorded during labor	during labor
Mode of delivery	Mode of delivery will be recorded (i.e. cesarean, spontaneous vaginal or instrumental vaginal delivery)	Delivery

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: John Coffman, MD, The Ohio State University Wexner Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 2, 2016
• First Submitted That Met QC Criteria: September 22, 2016
• First Posted (Estimated): September 23, 2016

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2016H0153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No